Over the last 10 years the 3D printing industry has changed dramatically. As materials and printing technologies have advanced, the shift into printing products for the human body has made exponential advances. We are seeing advances in medical device implants, tissue printing and the printing of 3D models to aid surgeons with complicated surgeries.
However, aside from the medical and health advantages, be prepared to navigate a somewhat “cloudy” regulatory landscape.
Advances in the medical device industry:
What are the FDA regulatory challenges and expectations for printed devices?
You can see more here: ASTM-F3049-14 Standard.
Advances in the Bio-printing industry:
“The lab’s global mission is to find solutions for a huge swathe of people who need to repair compromised organs or require transplant in the event of organ failure,” said Vladimir Mironov, the laboratory’s director of science. As the Skolkovo website reports, the Russian built bioprinter – which adds to a global line up currently comprising 14 different models – works by distributing so-called tissue spheroids, or bio-ink, in successive layers in a kind of scaffold structure made of hydrogel. The gel is then washed away, leaving behind three-dimensional tissue that matches a computer design down to the individual cell.”
What are the FDA regulatory challenges and expectations for bioprinting?
We may be 10 years off from final, FDA regulatory guidance in the bio-printing (and even drug printing) areas. Regardless, this technology should be watched closely. Research and development is moving forward and global military units are very interested in seeing advancement in this technology.
3D printing in the medical industry can no longer be ignored. Pediatric, plastic and cardiac surgeons are working with 3D printing labs to print scanned images of damaged or defective human organs. These printed models allow surgeons to view damage that could not be detected in 2D images. This technology is giving surgeons a customized road-map for complicated surgeries.
Could it be, we are truly facing the reality of “bionic” organs and body parts? It will be exciting to watch this innovative technology expand over the next few years.
Image courtesy of http://www.telegraph.co.uk: “3D printer builds new jaw bone” by Shane Richmond, Feb. 2012